A Single-arm, Open, Single-center Phase II Clinical Study on the Efficacy and Safety of SBRT Sequential Surufatinib Combined With Immunotherapy for Locally Unresectable or Recurrent Biliary Tract Cancer After First Surgery
Overview
- Phase
- Phase 2
- Intervention
- SBRT Sequential Surufatinib Combined With Immunotherapy
- Conditions
- Biliary Tract Carcinoma
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Objective response rate(ORR)
- Status
- Suspended
- Last Updated
- last year
Overview
Brief Summary
This is a single-arm, open, single-center Phase II clinical study to observe and evaluate the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in patients with locally unresectable or recurrent biliary tract cancer after the first surgery.
Detailed Description
This is a single-arm, open, single-center Phase II clinical study to observe and evaluate the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in patients with locally unresectable or recurrent biliary tract cancer after the first surgery.The study was divided into three stages: screening period, treatment period and follow-up period. During treatment, imaging methods were used to evaluate tumor status every 6 weeks (±7 days) until disease progression (PD, RECIST 1.1) or death (during treatment) or toxicity became intolerable, and tumor treatment and survival status after disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes.
Investigators
Liu luying
MD
Zhejiang Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •To be enrolled in this study, patients must meet all of the following criteria:
- •The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up;
- •Age 18-75 years old (including 18 and 75 years old), gender is not limited;
- •Patients with unresectable or untreated recurrent BTC confirmed by histopathology or cytology (including intrahepatic, extrahepatic, and gallbladder cancers);
- •Have not received any anti-tumor therapy before;
- •Have at least one measurable lesion (according to RECIST 1.1 standards); Magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement were used to accurately measure the diameter ≥10mm, and conventional CT scan was used to measure the diameter at least 20mm.
- •Normal liver volume (total liver volume minus tumor GTV volume) exceeds 1000cc;
- •The maximum diameter of the tumor is less than 10cm, allowing up to 3 satellite foci. Satellite foci were defined as being less than 2cm and within 1cm of the gross tumor.
- •No serious organic diseases of heart, lung, brain and other organs;
- •The main organs and bone marrow functions are basically normal:
Exclusion Criteria
- •The study proposal shall be excluded if any of the following criteria are met:
- •Have received any antitumor therapy in the past (except simple surgical resection);
- •The tumor directly invades the stomach, small intestine or colon;
- •The maximum diameter of the lesion exceeds 10cm, or the satellite lesion does not meet the above definition criteria;
- •Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- •There are extra-hepatic metastases (excluding local regional lymph nodes);
- •Normal liver volume is less than 1000cc;
- •The patient currently has hypertension that cannot be controlled by drugs, as follows: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
- •Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \>1.0g;
- •Patients whose tumors are judged by the investigators to be at high risk of invading vital blood vessels and causing fatal massive bleeding during the follow-up study;
Arms & Interventions
SBRT Sequential Surufatinib Combined With Immunotherapy
SBRT : Bioequivalent total dose \> 75Gy, completed within 2 weeks (once daily, 5 times a week). Drug treatment (every 3 weeks is a treatment cycle) : 1) Surufatinib: 200 mg, po, qd, taken continuously; 2) Carrelizumab: 200 mg/ time, intravenous drip on the first day of each cycle.
Intervention: SBRT Sequential Surufatinib Combined With Immunotherapy
Outcomes
Primary Outcomes
Objective response rate(ORR)
Time Frame: up to 12 months
The proportion of subjects in the analyzed population who developed complete response (CR) and partial response (PR) according to RECIST (version 1.1) criteria.
Secondary Outcomes
- Progression-free survival (PFS)(up to 12 months)
- Local control rate (LCR)(up to 12 months)
- Overall survival (OS)(up to 36 months)
- Incidence of adverse events （AE）(Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first))